Novartis gains rights to two oral targeted investigational therapies
focusing on patients with life-
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Ex-US rights acquired for JAK inhibitor INCB18424 in Phase III development as first-in-class treatment for myelofibrosis, a life-threatening blood disorder * Global rights acquired for early-stage cMET inhibitor INCB28060 targeting tumor invasion and drug resistance in certain cancers including gastric, kidney and lung * Novartis to make payments of USD 150 million upfront and first milestone of USD 60 million; Incyte eligible for milestone payments and royalties on future salesBasel, November 25, 2009 - Novartis has gained exclusive rights totwo oral targeted investigational therapies for patients with a rangeof life-threatening blood disorders and cancers that currently do nothave effective treatment options.Under a licensing agreement with Incyte Corporation, Novartis willhave responsibility for the future development of Incyte'sinvestigational JAK inhibitor outside the US and for futuredevelopment of an early-stage cmet inhibitor globally. * The lead compound is a Janus kinase (JAK) inhibitor with the investigational name INCB18424. This oral targeted therapy is in Phase III clinical trials for the treatment of myelofibrosis, a life-threatening neoplastic condition with no effective medical treatment[1] that is characterized by varying degrees of bone marrow failure, splenomegaly (enlarged spleen) and debilitating symptoms. INCB18424 has the potential of becoming a first-in-class therapeutic agent for the treatment of this and other hematologic diseases. * The second compound covered in the licensing agreement, a mesenchymal-epithelial transition factor kinase (cMET) inhibitor with the investigational name INCB28060, is entering Phase I development. Compounds in this class are envisioned to become effective cancer therapies through their ability to block molecular signals leading to tumor cell angiogenesis, proliferation, survival, invasion and metastasis. Multiple cancers have shown to be dependent on activation of molecular signals by genetic alterations of the cMET gene[2]. Emerging evidence indicates that cMET inhibition may be useful in the treatment of certain cancers, including gastric and kidney cancer[2], and may help to overcome resistance to some targeted therapies, such as gefitinib in non-small cell lung cancer[3]."A key Novartis priority is to bring innovative medicines to patientsas quickly as possible," said David Epstein, President and CEO,Novartis Oncology and Novartis Molecular Diagnostics. "This agreementleverages these two promising investigational drugs with NovartisOncology's global development and commercialization expertise and ourwide range of multi-targeted approaches to cancer treatment."Terms of the agreementNovartis will make an upfront payment of USD 150 million to Incyteand a first milestone payment of USD 60 million for initiation of theEuropean Phase III trial of the JAK inhibitor INCB18424 that began inJuly of this year. The agreement covers ex-US commercializationrights for the JAK inhibitor and global commercialization rights forthe cMET inhibitor INCB28060. Each company will be responsible forcosts in their respective territories for the JAK inhibitor, withcosts of collaborative studies shared equally. Novartis will beresponsible for all costs and activities for the cMET inhibitor afterthe Phase I clinical trial. After the first milestone, Incyte will beeligible for additional payments based on achieving defineddevelopment and commercialization milestones and to receive royaltieson future sales. Incyte also has an option to co-promote the cMETinhibitor in the US and to participate in the cMET inhibitor's globaldevelopment.DisclaimerThis release contains certain forward-looking statements relating tothe exclusive agreement concluded between Novartis and Incyte. Suchforward-looking statements are not historical facts and can generallybe identified by the use of forward-looking terminology such as "tomake," "eligible," "will," "potential," "about to enter," "envisionedto become," "may," "promising," or similar expressions, or by expressor implied discussions regarding potential future sales or earningsof Novartis; or by discussions of strategy, plans, expectations orintentions or potential synergies, strategic benefits oropportunities that may result from the proposed acquisition. Suchforward-looking statements reflect the current plans, expectations,objectives, intentions or views of Novartis with respect to futureevents and involve known and unknown risks, uncertainties and otherfactors that may cause actual results to be materially different fromany future results, performance or achievements expressed or impliedby such statements. In particular, there can be no guarantee that theproposed acquisition will be completed in the expected form or withinthe expected time frame or at all. Nor can there be any guaranteethat Novartis will achieve any particular future financial results orfuture growth rates or that Novartis will be able to realize any ofthe potential synergies, strategic benefits or opportunities as aresult of the proposed acquisition. Among other things, theexpectations of Novartis could be affected by unexpected regulatoryactions or delays or government regulation generally, as well asother risks and factors referred to in Novartis AG's Forms 20-F onfile with the US Securities and Exchange Commission. Novartis isproviding the information in this release as of this date and doesnot undertake any obligation to update any forward-looking statementsas a result of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com. # # #References:[1.] Hellman AJ. Myeloproliferative syndromes: diagnosis andtherapeutic options. Pol Arch Med Wewn. 2008;118:756-759.[2.] Gentile A, Trusolino L, Comoglio PM. The Met tyrosine kinasereceptor in development and cancer. Cancer Metastasis Rev. 2008Mar;27(1):85-94.[3.] Zucali PA, Ruiz MG, Giovannetti E, et al. Role of cMETexpression in non-small-cell lung cancer patients treated with EGFRtyrosine kinase inhibitors. Ann Oncol. 2008 Sep;19(9):1605-12.Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Kim FoxNovartis Global Media Relations Novartis Oncology+41 61 324 7999 (direct) +1 862 778-7692 (direct)+41 79 593 4202 (mobile) kim.fox(at)novartis.comeric.althoff(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1357027/329986.pdf --- End of Message ---Novartis International AGPostfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
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Datum: 25.11.2009 - 07:15 Uhr
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